For more information or a custom quote, visit the IHS Contact Us page for regional contact information.

Scope:

The procedures in this part apply when:

(a) The Commissioner concludes, as a matter of discretion, that
it is in the public interest to permit persons to present
information and views at a public hearing on any matter pending
before the Food and Drug Administation.

(b) The act or regulation specifically provides for a public
hearing before the Commissioner on a matter, e.g., § 330.10(a)(8)
relating to over-thecounter drugs and sections 520 (b) and
(f)(1)(B), and 521 of the act relating to proposals to allow
persons to order custom devices, to proposed device good
manufacturing practice regulations, and to proposed exemptions from
preemption of State and local device requirements under §
808.25(e).

(c) A person who has right to an opportunity for a formal
evidentiary public hearing under part 12 waives that opportunity
and instead requests under § 12.32 a public hearing before the
Commissioner, and the Commissioner, as a matter of discretion,
accepts the request.